Duns Number:961027315
Device Description: Monitoring Electrode, Neonatal, Prewired, Cloth
Catalog Number
EPP3CR
Brand Name
CARDINAL HEALTH
Version/Model Number
EPP3CR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053011,K053011,K053011
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
4d0374cf-98a4-471c-8c01-798568aff95d
Public Version Date
December 31, 2018
Public Version Number
6
DI Record Publish Date
August 17, 2016
Package DI Number
20885380048477
Quantity per Package
300
Contains DI Package
00885380048473
Package Discontinue Date
December 31, 2018
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |